"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
- Seasonal and perennial allergic rhinitis
- Vasomotor rhinitis
- Allergic conjunctivitis due to inhalant allergens and foods
- Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
- As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled
- Amelioration of the severity of allergic reactions to blood or plasma
DOSAGE AND ADMINISTRATION
The dosage of Karbinal ER should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated.
Administer Karbinal ER by the oral route only. Measure Karbinal ER with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. [see WARNINGS AND PRECAUTIONS
Adults and Adolescents 12 years of age and older
7.5 mL to 20 mL (6 to 16 mg) every 12 hours
Children 2 to 11 years of age (approximately 0.2 to 0.4 mg/kg/day)
2 to 3 years: 3.75 mL to 5 mL (3 to 4 mg) every 12 hours
4 to 5 years: 3.75 mL to 10 mL (3 to 8 mg) every 12 hours
6 to 11 years: 7.5 mL to 15 mL (6 to 12 mg) every 12 hours
Dosage Forms And Strengths
Extended-release oral suspension containing 4 mg carbinoxamine maleate per 5 mL
Storage And Handling
Karbinal ER contains 4 mg carbinoxamine maleate per 5 mL. It is a light beige to tan viscous suspension with strawberry banana flavor and is supplied as follows:
NDC 27808-046-02 bottles of 10 fl oz (300 mL)
NDC 27808-046-03 bottles of 16 fl oz (480 mL)
Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Dispense in tight, light-resistant container with child-resistant closure.
Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852. www.trispharma.com. Rev March 2013
Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Karbinal ER Information
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